FDA.reportPublic FDA data

MONDRIAN Lumbar Interbody Fusion Cage System

Primary DI
00841732124752
Brand
MONDRIAN Lumbar Interbody Fusion Cage System
Company
CTL Medical Corporation
Model
103.7161
Device description
Convex TLIF Disc Shaver, L28xH11mm
Published
2025-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121567000
K192863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121567000ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEMAccel Spine2012-09-26MAX
K192863000MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation2020-08-26MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732124752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732124752008417321247528417321247520841732124752

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(214)545-5820schedule@ctlmed.com
+1(214)545-5820schedule@ctlamedica.com

Regulatory Flags#

DUNS number
080138504
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841732135024MONDRIAN ALIF Cage with Supplementary Fixation Plate120.75002025-03-31
00841732141049MONDRIAN ALIF Cage with Supplementary Fixation Plate120.75022025-03-31
00841732142206GENERIC Surgical Instruments120.75082025-03-31
00841732142213MONDRIAN ALIF Cage with Supplementary Fixation Plate120.75102025-03-31
00841732142220MONDRIAN ALIF Cage with Supplementary Fixation Plate120.75202025-03-31
00841732142237MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76052025-03-31
00841732142244MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76092025-03-31
00841732142251MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76112025-03-31
00841732142268MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76132025-03-31
00841732142275MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76152025-03-31
00841732142282MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76172025-03-31
00841732142299MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76192025-03-31
00841732142305MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76212025-03-31
00841732142312GENERIC Surgical Instruments120.77002025-03-31
00841732142329GENERIC Surgical Instruments120.77012025-03-31
00841732142336GENERIC Surgical Instruments120.77022025-03-31
00841732142343GENERIC Surgical Instruments120.77102025-03-31
00841732142350GENERIC Surgical Instruments120.77202025-03-31
00841732142367GENERIC Surgical Instruments120.77252025-03-31
00841732142374GENERIC Surgical Instruments120.77302025-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02
08800043964268N/ATDM Co., Ltd.MAX2026-06-02